MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Model Number ER320

Device Problems Mechanical Problem (1384); Failure to Form Staple (2579)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to obtain additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent: please clarify " the jaw overlaps", was the jaw misaligned ? if other, please specify.Please provide the status of the device(s) as it has not been received for analysis.

Event Description

It was reported that during an unknown procedure, the clips "get out like x shape from the jaw overlaps.Surgeon used oversewing technique instead of clip applier.There was no patient consequence.

Manufacturer Narrative

(b)(4).Batch # u93l41.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the er320 device was returned with two clips jammed inside the shroud.Due to this condition, no further testing could be performed.Also, the jaws were examined for visual inspection and no damage or misaligned jaws were noted.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, the two clips were confirmed to be jammed and no other anomalies were observed.In addition, fourteen clips were found inside the clip track.No conclusion could be reached as to what may have caused the reported incident.It should be noted that product failure is multifactorial.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following: "caution: once the clip completely surrounds the vessel or tubular structure to be ligated and prior to starting the firing stroke, eliminate downward pressure so the structure to be ligated and the device jaws are pressure neutral to each other.This helps prevent the shifting of the clip position within the clip track and/or dislodgement".As part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4) date sent: 1/4/2021 h2: additional information received: please clarify " the jaw overlaps," was the jaw misaligned ? if other, please specify.No.I mean the clips take x shape when it get out from the jaw.H2: medical device problem code: is only failure to form staple (a050704).The device did not have a damaged jaw so mechanical problem (a05) medical device problem code should be removed.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11033692
• MDR Text Key: 222812122
• Report Number: 3005075853-2020-06973
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: U4063Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 03/23/2021
• Patient Sequence Number: 1